Global® AP™ Total Shoulder Arthroplasty (NCT00719771) | Clinical Trial Compass
CompletedNot Applicable
Global® AP™ Total Shoulder Arthroplasty
United States64 participantsStarted 2008-01
Plain-language summary
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
Exclusion Criteria:
* Are under 18 years of age or over 70
* Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
* Have a hemi-arthroplasty
* Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
* Have arthritis with insufficient cuff tissue
* Have had a failed rotator cuff surgery
* Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
* Have evidence of active infection
* Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
* Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
* Are skeletally immature.
* Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
* Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
* Are currently participating in another clinical study
* Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhal…